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Aesculap Implant Systems LLC Recall 90484

Description: ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.

Aesculap Implant Systems LLC Recall 90484 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-1391-2022
Event ID90484
Event DescriptionENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Product TypeDevices
DistributionUS Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.
Quantity67
Recall ReasonNonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Device Classification20220727
Device Code InfoUDI-DI (GTIN): 04046963419639
Center Classification Date20220715
Recall Initiation Date20191112
Recalling FirmAesculap Implant Systems LLC
Initial Notification Letter
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